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Misoprostol for primary versus secondary prevention of postpartum haemorrhage: a cluster‐randomised non‐inferiority community trial

OBJECTIVE: To assess whether secondary prevention, which preemptively treats women with above‐average postpartum bleeding, is non‐inferior to universal prophylaxis. DESIGN: A cluster‐randomised non‐inferiority community trial. SETTING: Health sub‐centres and home deliveries in the Bijapur district o...

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Detalles Bibliográficos
Autores principales: Raghavan, S, Geller, S, Miller, S, Goudar, SS, Anger, H, Yadavannavar, MC, Dabash, R, Bidri, SR, Gudadinni, MR, Udgiri, R, Koch, AR, Bellad, MB, Winikoff, B
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2016
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5014137/
https://www.ncbi.nlm.nih.gov/pubmed/26333044
http://dx.doi.org/10.1111/1471-0528.13540
Descripción
Sumario:OBJECTIVE: To assess whether secondary prevention, which preemptively treats women with above‐average postpartum bleeding, is non‐inferior to universal prophylaxis. DESIGN: A cluster‐randomised non‐inferiority community trial. SETTING: Health sub‐centres and home deliveries in the Bijapur district of Karnataka, India. POPULATION: Women with low‐risk pregnancies who were eligible for delivery with an Auxiliary Nurse Midwife at home or sub‐centre and who consented to be part of the study. METHODS: Auxiliary Nurse Midwifes were randomised to secondary prevention using 800 mcg sublingual misoprostol administered to women with postpartum blood loss ≥350 ml or to universal prophylaxis using 600 mcg oral misoprostol administered to all women during the third stage of labour. MAIN OUTCOME MEASURES: Postpartum haemoglobin ≤7.8 g/dl, mean postpartum blood loss and postpartum haemoglobin, postpartum haemorrhage rate, transfer to higher‐level facilities, acceptability and feasibility of the intervention. RESULTS: Misoprostol was administered to 99.7% of women as primary prevention. In secondary prevention, 92 (4.7%) women had postpartum bleeding ≥350 ml, of which 90 (97.8%) received misoprostol. The proportion of women with postpartum haemoglobin ≤7.8 g/dl was 5.9 and 8.8% in secondary and primary prevention clusters, respectively [difference −2.9%, one‐sided 95% confidence interval (CI) <1.3%]. Postpartum transfer and haemorrhage rates were low (<1%) in both groups. Shivering was more common in primary prevention clusters (P = 0.013). CONCLUSION: Secondary prevention of postpartum haemorrhage with misoprostol is non‐inferior to universal prophylaxis based on the primary outcome of postpartum haemoglobin. Secondary prevention could be a good alternative to universal prophylaxis as it medicates fewer women and is an acceptable and feasible strategy at the community level. TWEETABLE ABSTRACT: Secondary prevention of postpartum haemorrhage with misoprostol is non‐inferior to universal prophylaxis.